IRIS-CKD Program 2: Improving screening and management for chronic kidney disease in people with type 2 diabetes
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 2) (IRIS-CKD)
NA · Duke University · NCT06906640
This program will test whether a guided management program (plus education) helps doctors prescribe recommended CKD medicines for adults with type 2 diabetes and lab evidence of kidney disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT06906640 on ClinicalTrials.gov |
What this trial studies
IRIS-CKD Program 2 compares a guided management program to education alone to increase prescription of guideline-directed medical therapy (GDMT) for people with type 2 diabetes and chronic kidney disease. Eligible patients are identified through primary care at participating health systems, consented at site, given educational materials, and randomized to receive GDMT-guided management or education-only per site procedures. Prescribing will be measured over about six months using opportunity scores that account for variable indications for each medication. The primary outcome is whether the guided management approach increases appropriate prescriptions of ACEi/ARB, SGLT2 inhibitors, and finerenone as indicated.
Who should consider this trial
Good fit: Adults with type 2 diabetes who receive primary care within a participating health system, have laboratory evidence of CKD (e.g., UACR >300 mg/g, eGFR <45, or UACR ≥30 mg/g with eGFR <60), and are not already receiving 100% guideline-directed medical therapy are ideal candidates.
Not a fit: People with type 1 diabetes, very low eGFR (<20 ml/min/1.73 m2), prior kidney transplant, autosomal dominant polycystic kidney disease, active pregnancy, or those already fully treated with GDMT are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase use of proven kidney-protective medicines and help slow CKD progression in people with type 2 diabetes.
How similar studies have performed: Individual drug trials and some implementation efforts have improved CKD outcomes and medication uptake, but multi-site programs specifically designed to increase GDMT prescribing for CKD in T2D are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* (CKD Management)
* Adults with type 2 diabetes (T2D)
* Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
* Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):
* UACR \>300 mg/g or
* eGFR \<45 ml/min/1.73 m2 or
* UACR ≥30 mg/g with eGFR \<60 ml/min/1.73 m2
* Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).
Exclusion Criteria:
* (CKD Management)
* Type 1 diabetes
* Most recent eGFR \<20 ml/min/1.73 m2
* Prior kidney transplant
* Autosomal dominant polycystic kidney disease (ADPKD)
* Active pregnancy or plans for conception within 1 year
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama — Birmingham, Alabama, United States (RECRUITING)
- Orlando Health — St. Petersburg, Florida, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Essentia Institute of Rural Health — Duluth, Minnesota, United States (RECRUITING)
- Duke University — Durham, North Carolina, United States (RECRUITING)
- Baylor Scott & White — Temple, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Neha Pagidipati, MD — Duke University
- Study coordinator: Gretchen Sanders, MSN
- Email: gretchen.sanders@duke.edu
- Phone: 919 6687829
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Disease, Type 2 DM, Type 2 Diabetes Mellitus, CKD, T2DM, T2D, Type 2 Diabetes, Chronic kidney disease